Ticagrelor Approved in the U.S. to Reduce Risk of Stroke in Patients With Acute Ischemic Stroke or High-Risk Transient Ischemic Attack – Cath Lab…

New indication expands use of BRILINTA beyond cardio-vascular disease to patients with mild-to-moderate stroke

November 6, 2020 AstraZenecas BRILINTA(ticagrelor) has been approved in the U.S. to reduce the risk of stroke, a leading cause of disability and death worldwide, in patients with acute ischemic stroke (National Institutes of Health Stroke Scale score 5) or high-risk transient ischemic attack (TIA).

The approval by the US Food and Drug Administration (FDA) was based on positive results from the THALES Phase III trial that showed aspirin plus BRILINTA 90mg significantly reduced the rate of the composite of stroke and death compared to aspirin alone in patients with acute ischemic stroke or TIA.1The decision follows thePriority Review designationgranted by the FDA in July 2020.

Dr. Clay Johnston, lead investigator for the THALES Phase III trial and Dean of the Dell Medical School at The University of Texas in Austin, US, said: One in four patients who have had a stroke will experience a second one, with the risk particularly high within the first 30 days. The approval of BRILINTA in combination with aspirin is an important advancement to reduce the risk of recurrent stroke and much-awaited good news for physicians and patients.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: In the US, someone has a stroke every 40 seconds and the impact on a persons life can be truly devastating. BRILINTAis a well-established medicine across patients with coronary artery disease and with todays approval, we can now expand its potential to patients with an acute ischemic stroke or transient ischemic attack.

The THALES trial demonstrated that BRILINTA 90mg used twice daily and taken with daily aspirin for 30 days, reduced the rate of the primary composite endpoint of stroke and death by 17% (absolute risk reduction = 1.1%; hazard ratio 0.83; 95% confidence interval 0.71-0.96, p=0.015), compared to aspirin alone in patients with an acute ischemic stroke or TIA.1This was a statistically significant and clinically meaningful reduction. The primary composite endpoint was driven by a reduction in stroke.

The risk for severe bleeding events was 0.5% in patients receiving aspirin plus BRILINTA and 0.1% for aspirin alone. The results were in line with the known safety profile of BRILINTA.1Full data from the THALES Phase III trial can be found inThe New England Journal of Medicine.

Regulatory submissions to expand the approved indication are also under regulatory review in China and in the EU where the medicines name isBrilique.

BRILINTAis approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS) and in more than 70 countries for the secondary prevention of cardiovascular events among patients who are at high-risk and have experienced a heart attack. In May 2020, the US FDA approved anew indicationforBRILINTAto include the reduction of the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.

INDICATIONS

DOSING

IMPORTANT SAFETY INFORMATION FOR BRILINTA(ticagrelor) 60-MG AND 90-MG TABLETS

WARNINGS:

A. BLEEDING RISK

B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS IN PATIENTS WITH ACS

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

SPECIAL POPULATIONS

Please read fullPrescribing Information, including Boxed WARNINGS, andMedication Guide.

Stroke An ischemic stroke is caused by a blockage cutting off the blood supply to a region of the brain. A transient ischemic attack, is a temporary blockage of the blood supply to a region of the brain, resulting in symptoms only lasting for a short amount of time. Stroke is a leading cause of disability and death worldwide.2In the US, someone has a stroke every 40 seconds, and every four minutes, someone dies of stroke.3About one in four strokes are recurrent, with the risk particularly high within 30 days after the initial event and even higher when looking at time periods closer to the initial event.4,5

THALES THALES is an AstraZeneca-sponsored, randomized, placebo-controlled, double-blinded, international, multicenter, event-driven Phase III trial involving more than 11,000 patients from 28 countries. It tested the hypothesis whether aspirin plusBRILINTAis superior to aspirin alone in preventing the composite of stroke and death in patients with non-cardioembolic acute ischemic stroke or high-risk TIA. Patients were randomized within 24 hours of onset of acute ischemic stroke or high-risk TIA symptoms and treated for 30 days. Study treatments wereBRILINTA180mg loading dose on day 1, followed by 90mg twice daily on days 2-30, or matching placebo. All patients received open-label aspirin 300-325mg on day 1, followed by 75-100mg once daily on days 2-30. The primary efficacy outcome was the time to the composite endpoint of stroke and death at 30 days. The primary safety outcome is time to first severe bleeding event according to the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) definition, which includes fatal bleedings, intracranial hemorrhage; and bleeding causing hemodynamic compromise requiring intervention.

AstraZeneca in CV, Renal & Metabolism (CVMD) CV, renal and metabolism together form one of AstraZenecas main therapy areas and a key growth driver for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVMD diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and CV health for millions of patients worldwide.

About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visitwww.astrazeneca-us.comand follow us on Twitter@AstraZenecaUS.

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Ticagrelor Approved in the U.S. to Reduce Risk of Stroke in Patients With Acute Ischemic Stroke or High-Risk Transient Ischemic Attack - Cath Lab...